Full Statement from the FDA

Posted on

The FDA's goal is to balance the important public health concerns around the misuse and abuse of prescription opioids with the need for continued access to effective pain medications for the millions of patients experiencing both short-term and chronic, debilitating pain. As a single hydrocodone product, Zohydro fulfills a unique need without the associated liver toxicity risk of the combination opioids that include acetaminophen. The inappropriate use of opioids is a major public health challenge that has reached epidemic proportions in the U.S. However, FDA cannot combat this problem alone. We are committed to working with the medical and patient communities, which share the responsibility to address this issue. Prescribers play a particularly critical role in terms of responsible prescribing and education.